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Biodiversity Protection - Ipr Group

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    BIODIVERSITY PROTECTIONPROJECT

    TOPIC:-

    LEGAL ISSUE RELATING TO

    BIOPROSPECTING

    1

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    INDEX

    S. NO. CONTENTS PAGE NO.

    1. MEANING OF BIODIVERSITY 4

    2. MEANING OF BIOPROSPECTING AND

    BIOPIRACY

    5

    3. LEGAL ISSUES RELATING TO

    BIOPRSPECTING AND BIOPIRACY

    6

    4. CONVENTION ON BIOLOGICAL DIVERSITY

    ON BIOPIRACY

    5. TRIPS AGREEMENT ON BIOPIRACY !

    6. FAMOUS CASES RELATING TO

    BIOPROSPECTION AND BIOPIRACY

    "-16

    . CONCLUSION 1

    !. BIBLIOGRAP#Y 16

    2

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    MEANING OF BIODIVERSITY

    Biodiversity comes from a contraction of biological diversity.

    "Biological diversity" means the variability among living organisms from all sources and the

    ecological complexes of which they are part, and includes diversity within species or between

    species and of eco-systems.1

    "Biological diversity" means the variability among living organisms from all sources

    including, inter alia, terrestrial, marine and other aquatic ecosystems and the ecological

    complexes of which they are part; this includes diversity within species, between species and

    of ecosystems.

    !owever, the concept has been politicied since the C$%&'%()$% $* B)$+$,)+ D)&'/0)( of 

    1##, and ever since it is strongly associated with the conservation of species of the country

    or region.

    •$he biodiversity varies greatly with ecosystems and climates. $he humid tropics have the

    greatest biodiversity, while the biodiversity decreases towards the north and south as the

    temperatures decrease. %lso, less humidity is associated with decreasing species density.

    &urthermore, stress is reversely related to biodiversity, e.g.'

    • •  poor drainage, water-logging and seasonal flooding;

    • • &ire

    • • very eutrophic and oligotrophic conditions

    1 (ection )b*, $he Biological +iversity %ct,

    2 %rticle , onvention on Biodiversity

    3

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    • • estuarine conditions with fluctuating salinity andor great tidal difference

    • • long seasonal draughts

    %ll tend to lower species densities. !owever, such stress conditions all have species that are

    well adapted to the stress factors, and ecological variant leads to the occupation of a different

    assemblage of species./

    MEANING OF BIOPROSPECTING

    B)$/$0'()%, is the process of discovery and commercialiation of new products based on

     biological resources. +espite being intuitively helpful, bioprospecting has only recently

     begun to incorporate indigenous 0nowledge in focusing screening efforts for bioactive

    compounds.

    Bioprospecting also includes biopiracy' the exploitative appropriation of indigenous forms of 

    0nowledge by commercial actors. %s well as the search for previously un0nown compounds

    in organisms that have never been used in traditional medicine before.

    Bioprospecting can be defined as the systematic search for and development of new sources

    of chemical compounds, genes, micro-organisms, macro-organisms, and other valuable

     products from nature.

    MEANING OF BIOPIRACY

    Biopiracy is a problem among developing countries where indigenous peoples have great

    0nowledge over plants that carry medicinal properties. 2ndividual scientists or corporations

    go to different developing countries, learn about the indigenous peoples3 0nowledge about

    certain plants or substances, then go bac0 to the scientist3s or corporation3s native country and

     patent it there, giving the indigenous people none or very little compensation.

    3 http'www.cbd.int1biodiversity

    4 4Bioprospecting' % 5ew 6estern Bloc0buster, %fter the 7old 8ush, the 7ene 8ush", luis orinne

    )1/*.

    4

    http://www.cbd.int/2010/biodiversity/http://www.scq.ubc.ca/bioprospecting-a-new-western-blockbuster-after-the-gold-rush-the-gene-rush/http://www.scq.ubc.ca/bioprospecting-a-new-western-blockbuster-after-the-gold-rush-the-gene-rush/http://www.cbd.int/2010/biodiversity/

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    Bioprospecting, if well managed, can be advantageous, since it can generate income for 

    developing countries, and at the same time it can provide incentives for the conservation of 

     biological resources and biodiversity. 2n addition, it can lead to the development of new

     products, including for example new medicines.

    9n the other hand, if not well managed, bioprospecting may create a number of problems,

    including environmental problems related to unauthoried over- exploitation, and social and

    economic problems related to unfair sharing of benefits -or the total absence of benefit

    sharing- and to disrespect for the rights, 0nowledge and dignity of local communities.:

    LEGAL PROVISIONS RELATING TO

    BIOPROSPECTING AND

    BIOPIRACY

    $here are two international conventions that can be applied when dealing with biopiracy, itis'-

    • $he onvention on Biological +iversity )the B+*; and

    • $he %greement on $rade-8elated %spects of 2ntellectual roperty 8ights )$82(*.

    $he main goal of the B+ is to preserve biological diversity while the goal of $82( is to

    stimulate technological advancement, giving individual rights to the inventor through

    intellectual property rights )28s*.

    (ome say there is a conflict between the two %greements, others say there is none. %s will be

    shown later, it is appropriate to say that the ones claiming that there is no conflict are the ones

    who are dependent on 28s < that is, the pharmacy corporations and scientists < and the ones

    saying that there is a conflict are the indigenous people who are the victims of biopiracy and

    the ones advocating their interests.

    5 http'apps.who.intmedicinedocsend=h##>e>./.html

    5

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    $he indigenous people need the protection which the B+ and $82( in combination,

    according to them, fails to give them. $he pharmacy corporations and scientists want more

    freedom to continue their research all over the world and protect their eventual inventions;

    therefore they claim that there is no conflict.>

    CONVETION ON BIOLOGICAL

    DIVERSITY

    % big step was made in 1## when the onvention on Biological +iversity )the B+* came

    into force. $his convention gave sovereign national rights over biological resources.? 

    9ne of the advantages of it is that it enables developing countries to better benefit from their 

    result of traditional 0nowledge. @nder these rules, one might expect that bioprospecting

    implies a prior informed consent and that it must result in a shared benefits between the

     biodiversity-rich country and the prospecting firm. (ome critics say that the B+ must

    establish appropriate regulations to prevent biopiracy.A

    $he obectives of the B+ are conservation of biological diversity, sustainable use of its

    components and the fair and equitable sharing of the benefits arising out of the utilisation of 

    genetic resourcesA. $he two most important articles in the B+, concerning biopiracy are

    %rticle A)* and %rticle /.

     Article 3 recognises the sovereign rights states have in accordance with the harter of the

    @nited 5ations and the principle of international law'-

    6 https'lup.lub.lu.seluurdownloadCfuncDdownload&ileErecord92dD1:>1/A?Efile92dD1:>:>1#

    7 onvention on Biological +iversity, %rticle /.

    8 https'lup.lub.lu.seluurdownloadCfuncDdownload&ileErecord92dD1:>1/A?Efile92dD1:>:>1#

    6

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    4the sovereign right to exploit their own resources pursuant to their own environmental

     policies, and the responsibility to ensure that activities within their urisdiction or control do

    not cause damage to the environment of other (tates or of area beyond the limits of national

     urisdiction.F

     Article 8(i) of the CBD which reads:-

    4Gach ontracting arty shall, as far as possible and as appropriate'H (ubect to its national

    legislation, respect, preserve and maintain 0nowledge, innovations and practices of 

    indigenous and local communities embodying traditional lifestyles relevant for the

    conservation and sustainable use of biological diversity and promote their wider application

    with the approval and involvement of the holders of such 0nowledge, innovations and

     practices and encourage the equitable sharing of the benefits arising from the utilisation of 

    such 0nowledge, innovations and practices.F

    TRIPS AGREEMENT ON

    BIOPIRACY

     Article 27 of TRIPS

    %rticle ? requires Iembers to recognise both product and patent processes without any

    discrimination as to the field of technology, which includes biotechnology.

     Article 272 allows members to exclude from patentability inventions so as to protect order 

     public or morality. 9rder public and morality include the protection of human, animal or 

     plant life or health and the avoidance of serious preudice to the environment.

    2n ma0ing use of %rticle ?. Iembers will need to bear in mind their general obligation

    under %rticle A of $82( to adopt measures that are 4consistent with the provisions of this

    %greementF.

    7

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    $his ma0es it possible for a Iember of $82( who finds biopiracy to be against the

     protection of order public or morality to prevent biopiracy through %rticle ?. of $82( and

    thereby exclude the patentability. 2n this sense, the B+ and $82( interact in a perfect

    manner. 2t is though, a fundamental axiom of G@ and @( patent law that exceptions to patent

    law are to be narrowly construed.

    FAMOUS CASES RELATING TO

    BIOPROSPECTING AND

    BIOPIRACY

    T!"#RIC CAS# 

    $urmeric )urcuma longa* has anti-biotic, ant-inflammatory, antioxidant and coagulant

     properties. 2t also has been used externally to heal sores and as a cosmetic.

    @( patent was granted to two @(-based 2ndians -  S$%a& ' Das a&d ari ar P Cohl of 

    @niversity of Iississippi Iedical enter, @(%. on the use of turmeric in wound healing in

    1##:.

    8

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    $he ouncil of (cientific E 2ndustrial 8esearch )(28*, 2ndia challenged the novelty of 

     patent. (28 requested the @( atent and $rademar0 9ffice )@($9* for re-examination of 

     patent.

    $he council argued that use of turmeric to heal wounds and rashes has been 0nown for 

    centuries so this invention was not novel. (28 after difficult searching could locate /

    referencesA to prove their claim. $he @( atent 9ffice revo0ed this patent in 1##? on the

     basis of evidence provided by (28.

    $his case is the ust an initiation of the movement of preserving and avoiding misuse of 

    traditional 0nowledge. $he requirement of fixation of prior art in a tangible, accessible form

    under the @.(. patent law, ma0e it difficult to challenge patents based on traditional

    0nowledge.

    Iost of the 0nowledge of the indigenous peoples is undocumented and passed from

    generation to generation orally. $herefore, a need was felt to create more easily accessible

    and technical non-patent literature databases on traditional 0nowledge of 2ndia. #

    THE ROSY PERIWINKLE

    $he rosy periwin0le case dates from the 1#:s. $he rosy periwin0le, while native

    to Iadagascar , had been widely introduced into other tropical countries around the world

    well before the discovery of  vincristine )medicine for cancer*.

    9 http'www1.american.edutedturmeric.htm

    9

    http://en.wikipedia.org/wiki/Rosy_periwinklehttp://en.wikipedia.org/wiki/Madagascarhttp://en.wikipedia.org/wiki/Madagascarhttp://en.wikipedia.org/wiki/Madagascarhttp://en.wikipedia.org/wiki/Vincristinehttp://en.wikipedia.org/wiki/Vincristinehttp://en.wikipedia.org/wiki/Vincristinehttp://en.wikipedia.org/wiki/Rosy_periwinklehttp://en.wikipedia.org/wiki/Madagascarhttp://en.wikipedia.org/wiki/Vincristine

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    $his meant that researchers could obtain local 0nowledge from one country and plant

    samples from another.

    $he use of the plant as a cure for diabetes was the original stimulus for research, but potential

    for cancer  treatment were also explored )5GG+ 8G&G8G5G(*.

    +ifferent countries are reported as having acquired different beliefs about the medical

     properties of the plant. $he !odg0inJs lymphoma chemotherapeutic drug vinblastine is also

    derivable from the rosy periwin0le.1

     *##" TR## CAS# 

    10 Karasov, . )1*."6ho 8eaps the Benefits of BiodiversityC"

    10

    http://en.wikipedia.org/wiki/Diabeteshttp://en.wikipedia.org/wiki/Diabeteshttp://en.wikipedia.org/wiki/Cancerhttp://en.wikipedia.org/wiki/Cancerhttp://en.wikipedia.org/wiki/Hodgkin's_lymphomahttp://en.wikipedia.org/wiki/Hodgkin's_lymphomahttp://en.wikipedia.org/wiki/Vinblastinehttp://www.ncbi.nlm.nih.gov/pmc/articles/PMC1240518http://en.wikipedia.org/wiki/Diabeteshttp://en.wikipedia.org/wiki/Cancerhttp://en.wikipedia.org/wiki/Hodgkin's_lymphomahttp://en.wikipedia.org/wiki/Vinblastinehttp://www.ncbi.nlm.nih.gov/pmc/articles/PMC1240518

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    $he patent was granted by the Guropean atent 9ffice to +R ,race Co%a&  and @(

    +epartment of %griculture on a fungicide derived from 5eem in 1##. $he active ingredient

    was isolated from the seeds of plant.

    $he company and @(+ got patent on the method of ma0ing a stabilied aadirachtin in

    solution and the stabilied aadirachtin solution itself.

    $his solution was introduced as a pesticide in the mar0et .$he process of isolating and

     purification of the substance satisfies the grounds of novelty and inventive step as required

    under laws.

    $he ground on which validity of patent can be challenged is that said use is available in a

    fixed tangible form and well documented in a printed publication.

    % group of international 579s and representatives of 2ndian farmers filed legal opposition

    against the patent on the grounds that fungicidal effect of extracts of 5eem seeds had beenused for centuries in 2ndian agriculture.

    %fter a long battle in : Guropean atent 9ffice upheld the revocation of 5eem atent.11

     #*./A B#A*S CAS# 

    $he Gnola bean is a variety of Iexican yellow bean, so called after the wife of the man who

     patented it in 1###.

    11 ormac (herida. 5ature Biotechnology /):*':11-1. Iay :. G9 neem patent revocation

    revives biopiracy debate

    11

    http://www.nature.com/nbt/journal/v23/n5/pdf/nbt0505-511.pdfhttp://www.nature.com/nbt/journal/v23/n5/pdf/nbt0505-511.pdfhttp://www.nature.com/nbt/journal/v23/n5/pdf/nbt0505-511.pdfhttp://www.nature.com/nbt/journal/v23/n5/pdf/nbt0505-511.pdf

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    $he allegedly distinguishing feature of the variety is seeds of a specific shade of yellow.

    $he patent-holder subsequently sued a large number of importers of Iexican yellow beans

    with the following result' "...export sales immediately dropped over #L among importers

    that had been selling these beans for years, causing economic damage to more than ,

    farmers in northern Iexico who depended on sales of this bean."

    % lawsuit was filed on behalf of the farmers, and on %pril 1, : the @(-$9 ruled in

    favour of the farmers. %n appeal was heard on 1> th =anuary A, and the patent was revo0ed

    in Iay A.

    %n appeal to the court against the revocation was unsuccessful )+ecided 9ctober #*. 1

     BAS"ATI RIC# CAS# 

    @( atent was granted to 8ice $ec 2nc., @(% in 1##? entitled "Basmati 8ice Mines and

    7rains".

    12 7oldberg, +anielle )/*. "=ac0 and the Gnola Bean"

    12

    http://www1.american.edu/TED/enola-bean.htmhttp://www1.american.edu/TED/enola-bean.htmhttp://www1.american.edu/TED/enola-bean.htm

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     5ew rice lines were derived via crossing semi-dwarf varieties with traditional varieties of 

     basmati from 2ndia and a0istan.

    atent document contain claims that covers not only novel rice lines developed from rice

    germplasm but also covers various varieties which were based on traditional farmer-bred

    verities.

    Ioreover 8ice $ec also hiac0ed the term NBasmati3 and by doing so the company claimed

    exclusive ownership over new varieties based on traditional rice varieties nurtured by

    generations of farmers.

    $he particular characteristics li0e fragrant aroma, long and slender grain and distinct taste of 

    Basmati are due to the geographical region )greater unab region divided between 2ndia and

    a0istan* in which it grows.

    (o this company was misleading the public towards different and inferior product and alsoadversely affected the export mar0et of 2ndia and a0istan.

    $he 7overnment of 2ndia under pressure of 5on-7overnment 9rganiations )579s* filed a

    request for re-examination in the year on the ground that rice lines in question lac0 

    inventiveness and novelty.

    2n the year 1, in response to request, @($9 only allowed : claims )three independent

    claims A, #, 11 and their dependent claims 1 E 1/* out of and title of the invention was

    also changed from 4Basmati 8ice Mines and 7rainsF to 48ice MinesF. 1/

     ..DIA P/A*T CAS# 

    13 http'www.grain.orgseedlingCidD:#

    13

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    !oodia, a succulent plant, originates from the Kalahari +esert of (outh %frica.

    &or generations it has been 0nown to the traditionally living(an  people as an appetite

    suppressant.

    2n 1##> (outh %frica3s ouncil for (cientific and 2ndustrial 8esearch  began wor0ing with

    companies, including @nilever , to develop dietary supplements based on hoodia.

    9riginally the (an people were not planned to receive any benefits from the

    commercialiation of their traditional 0nowledge, but in / the (outh %frican (an ouncil

    made an agreement with (28 in which they would receive from > to AL of the revenue from

    the sale of !oodia products.

    2n A after having invested O million in 8E+ on hoodia as a potential ingredient

    in dietary supplements for weight loss, @nilever terminated the proect because their clinical

    studies did not show that hoodia was safe and effective enough to bring to mar0et.1

    CONCLUSION

    2n order to chec0 bio-piracy, it is imperative to bring about a comprehensive change in the

    intellectual property system the world over, through appropriate amendments in the $82(

    %greement, which codifies the rules for the protection of intellectual property internationally.$hree principles, that are required to prevent bio-piracy, should be included in $82(.

    $hese principles are' -

    • +isclosure of the geographical origin of biological resources or related traditional

    0nowledge used in invention.

    • 9btaining prior informed consent of the relevant local community.

    • Gnsuring equitable benefit sharing arrangements.

    14 6ynberg, 8achel )1/-1-1/*. "!ot air over !oodia

    14

    http://en.wikipedia.org/wiki/Hoodiahttp://en.wikipedia.org/wiki/Succulent_planthttp://en.wikipedia.org/wiki/Kalahari_Deserthttp://en.wikipedia.org/wiki/South_Africahttp://en.wikipedia.org/wiki/San_peoplehttp://en.wikipedia.org/wiki/San_peoplehttp://en.wikipedia.org/wiki/Appetite_suppressanthttp://en.wikipedia.org/wiki/Appetite_suppressanthttp://en.wikipedia.org/wiki/Council_for_Scientific_and_Industrial_Researchhttp://en.wikipedia.org/wiki/Council_for_Scientific_and_Industrial_Researchhttp://en.wikipedia.org/wiki/Unileverhttp://en.wikipedia.org/wiki/Dietary_supplementshttp://en.wikipedia.org/wiki/Dietary_supplementshttp://www.grain.org/article/entries/4047-hot-air-over-hoodiahttp://en.wikipedia.org/wiki/Hoodiahttp://en.wikipedia.org/wiki/Succulent_planthttp://en.wikipedia.org/wiki/Kalahari_Deserthttp://en.wikipedia.org/wiki/South_Africahttp://en.wikipedia.org/wiki/San_peoplehttp://en.wikipedia.org/wiki/Appetite_suppressanthttp://en.wikipedia.org/wiki/Appetite_suppressanthttp://en.wikipedia.org/wiki/Council_for_Scientific_and_Industrial_Researchhttp://en.wikipedia.org/wiki/Unileverhttp://en.wikipedia.org/wiki/Dietary_supplementshttp://www.grain.org/article/entries/4047-hot-air-over-hoodia

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    +efinition of prior art is different in different countries, the atent %ct of 2ndia has provision

    that if an invention which in effect, is traditional 0nowledge or which is an aggregation or 

    duplication of 0nown properties of traditionally 0nown component or components3 is not

     patentable.

    $his provision can prevent bio-piracy within the territory of 2ndia but cannot protect

    traditional 0nowledge outside 2ndia, for example in @(% such subect matter is considered

     patentable and only scientifically authenticated printed publications are considered as prior 

    art.

    $here is need to harmonie the definition of prior art on international basis.

    Ian0ind has two basic obectives' to survive and to reproduce.

    $he survival obective can be strengthened through medicine and this is the reason why it is

    so important for us to preserve the 0nowledge of plants having these abilities.

    6e must remember that scientists and pharmaceutical corporations have to 0eep doing there

    research in order to ma0e the world healthier and this includes bioprospecting.

    Bioprospecting can however be done in a legal, moral and appropriate way.

    6e must remember that bioprospecting is not the same as biopiracy.

    $he issue of biopiracy must be solved and a maor insight is that the world has to come

    together and realise that these plants and substances actually can save lives. Be oyful, you

     plants that bear flowers and those that bear fruitP

    BIBLIOGRAP#Y

    $he following references were referred to while completing this proect'-

    EBSITES:-

    • http'www.cbd.int1biodiversity

    • http'www.grain.orgseedlingCidD:#

    • http'www1.american.edutedturmeric.htm

    https'lup.lub.lu.seluurdownloadCfuncDdownload&ileErecord92dD1:>1/A?Efile92dD1:>:>1#

    15

    http://www.cbd.int/2010/biodiversity/http://www.grain.org/seedling/?id=59http://www1.american.edu/ted/turmeric.htmhttps://lup.lub.lu.se/luur/download?func=downloadFile&recordOId=1561387&fileOId=1565619https://lup.lub.lu.se/luur/download?func=downloadFile&recordOId=1561387&fileOId=1565619http://www.cbd.int/2010/biodiversity/http://www.grain.org/seedling/?id=59http://www1.american.edu/ted/turmeric.htmhttps://lup.lub.lu.se/luur/download?func=downloadFile&recordOId=1561387&fileOId=1565619https://lup.lub.lu.se/luur/download?func=downloadFile&recordOId=1561387&fileOId=1565619

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    • http'apps.who.intmedicinedocsend=h##>e>./.html

    ARTICLES:-

    • 6ynberg, 8achel, "!ot air over !oodia )1/*

    • ormac (herida, 5ature Biotechnology)Iay :*.

    • 7oldberg, +anielle, "=ac0 and the Gnola Bean" )/*

    • Karasov, . ,"6ho 8eaps the Benefits of BiodiversityC" )1*

    • luis orinne, Bioprospecting' % 5ew 6estern Bloc0buster, %fter the 7old 8ush, the 7ene

    8ush", )1/*.

    16

    http://apps.who.int/medicinedocs/en/d/Jh2996e/6.3.htmlhttp://www.grain.org/article/entries/4047-hot-air-over-hoodiahttp://www.grain.org/article/entries/4047-hot-air-over-hoodiahttp://www.grain.org/article/entries/4047-hot-air-over-hoodiahttp://www1.american.edu/TED/enola-bean.htmhttp://www1.american.edu/TED/enola-bean.htmhttp://www.ncbi.nlm.nih.gov/pmc/articles/PMC1240518http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1240518http://www.scq.ubc.ca/bioprospecting-a-new-western-blockbuster-after-the-gold-rush-the-gene-rush/http://www.scq.ubc.ca/bioprospecting-a-new-western-blockbuster-after-the-gold-rush-the-gene-rush/http://apps.who.int/medicinedocs/en/d/Jh2996e/6.3.htmlhttp://www.grain.org/article/entries/4047-hot-air-over-hoodiahttp://www1.american.edu/TED/enola-bean.htmhttp://www.ncbi.nlm.nih.gov/pmc/articles/PMC1240518http://www.scq.ubc.ca/bioprospecting-a-new-western-blockbuster-after-the-gold-rush-the-gene-rush/http://www.scq.ubc.ca/bioprospecting-a-new-western-blockbuster-after-the-gold-rush-the-gene-rush/